For purposes of the present invention, the term "operator" is intended to encompass any of a number of practitioners specifically in the medical field including, but not limited to, urologists, doctors, nurses, technicians, surgeons, medical instrument operators and the like.
In the process of conducting certain physical examinations and surgical procedures, especially urological, gynecological or proctological procedures, close contact with the patient's genital region is required. An example of a standard surgical procedure involves the use of an endoscope. An endoscope is a urological instrument for performing tests and therapies involving the urinary tract. Basically, the endoscope is a long cylindrical instrument which traverses the urethra to diagnose a condition, i.e., by a camera or visual lens at the distal end of the endoscope, or to perform an operation. Any time an operator is using an endoscope, there is an unusually high risk of splatter contamination from fluids flowing from the patient's body. Aside from the obvious unpleasant and unhygienic conditions, the potential of body fluid contact creates a health risk to the operator.
To alleviate this concern, protective barriers have been developed to be placed between the patient and the operator. Prior art devices used to avoid contamination include wearing gloves, surgical caps, masks and goggles. Protective clothing, while helpful, provides a limited barrier because of the opportunity for fluids to pass between the articles of clothing, for example between the surgical cap and gown. Goggles tend to fog due to condensation, and the operator cannot place his eye on the ocular portion of the endoscope. Another barrier device is the use of a video camera wherein the operator can watch a video camera to the side of the patient and perform the operation. Video units, however, are expensive and unwieldy.
Yet another device on the market for preventing contamination is an endoscopic splash shield, such as that produced by Cook Urological Company and protected under U.S. Pat. No. 4,834,068 to Gottesman. A splash shield is a transparent disk approximately 12 inches in diameter with a central aperture for receiving a surgical instrument, e.g., an endoscope. While splash shields protect the operator from some contamination, their effectiveness is limited primarily because of limited size and the potential for fluid splash over and around the shield. A similar device is described and illustrated in Whelan, J. Paul and Birdwell Finlayson, 1991, "Decreasing the Risk of Human Immunodeficiency Virus or Hepatitis B Virus Infection During Endoscopic Surgery," J. Urol., Vol. 145, pp. 807-809.
Another form of protection is the surgical drape. Surgical drapes are generally flexible sheets designed to drape or wrap over a patient and provide a barrier between the patient and the operator. For example, U.S. Pat. No. 4,903,710 to Jessamine et al. is directed to a surgical isolation drape for use in urological, gynecological or proctological surgical procedures. The surgical drape includes a sheet of flexible transparent or translucent plastic material. The central portion of the sheet is provided with apertures sealed by flexible members to permit passage of the surgeon's hands. The sheet can also be provided with a sealable aperture for permitting ocular access to the lens of a urological instrument. While the Jessamine et al. drape provides a patient/operator barrier, it may restrict procedures which require frequent bladder emptying. The drape also has an open top which will allow spray to pass over the drape and thus contaminate the operator's face and hands.
U.S. Pat. No. 4,596,245 to Morris describes a surgical drape for urological purposes. The drape contains a central area with a circular fenestration in the plastic drape. The fenestration is used to allow angiographic wires to be fed from the body of a patient through the fenestration when the drape is placed on the patient.
U.S. Pat. No. 4,690,137 to Starzmann discloses a surgical drape for use with urethral surgical procedures. This drape is basically a collection bowl in that it includes what is a term an annulus near the mid-portion of the drape. The apparent purpose of the annulus is to palpate the patient.
The prior art drapes, while useful to a degree, suffer a variety of deficiencies. Many simply do not prevent adequate splatter contamination control. Some, such as the Jessamine et al. invention, are complicated to operate.